MAUDE Adverse Event Report: LIFE SPINE, INC. LIFE SPINE; PRO LIFT

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 09/15/2019

Event Type  malfunction  

Manufacturer Narrative

The correct sized implant was not chosen for the surgery, the implant worked as intended however the wrong size was chosen by the surgeon.

Event Description

The implant was pushing it self out because the surgeon had used an implant that was too small.

• Brand Name: LIFE SPINE
• Type of Device: PRO LIFT
• Manufacturer (Section D): LIFE SPINE, INC.; 13951 s. quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE, INC.; 13951 s. quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 s. quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 9215936
• MDR Text Key: 196140049
• Report Number: 3004499989-2019-00005
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other